Fentanyl pectin nasal spray (FPNS) with PecSys®: efficacy, tolerability, and onset of action in the treatment of breakthrough cancer pain (BTCP)

Abstract

Most BTCP episodes have a time course that does not match the typical analgesic time course of oral rescue medication. FPNS is a new nasal fentanyl formulation for BTCP. To assess efficacy and safety/tolerability of FPNS, patients (N = 114) experiencing 1–4 BTCP episodes/day while taking >60 mg/day of morphine (or equivalent) entered a randomized, placebo-controlled, double-blind (DB) study (Archimedes CP043). Those who completed an open-label titration phase (N = 83) were treated for 10 episodes of BTCP in DB fashion; effective dose (7) or placebo (3). Pain intensity (PI) was measured using an 11-point scale, pain relief (PR) a 5-point scale. Primary endpoint was the summed pain intensity difference at 30 min (SPID30). Secondary endpoints included pain outcomes measured at 5, 10, 15, 30, 45 and 60 min post-dose. Safety/tolerability were assessed by adverse events (AEs) and objective and subjective nasal assessments. FPNS significantly improved mean SPID30 score compared with placebo (P < 0.0001; modified intent-to-treat N = 73) and provided significant improvements in SPID from 10 min (P < 0.01) to 60 min (P < 0.0001). Significant differences in favor of FPNS were found in PI as early as 5 min (P < 0.05). Similar changes were seen with PID, with a trend at 5 min (P = 0.07) that was significant from 10 min onward (P < 0.01). Pain relief was also significant from 10 min (P < 0.001) and at all time points to 60 min (P < 0.001). Only 5.3% of patients withdrew from titration (1.2% in DB phase) due to AEs; no significant nasal effects were reported. This study demonstrates that FPNS is safe, efficacious, and has a relatively rapid onset of action in patients with BTCP. (Sponsored by Archimedes Development Ltd.)